The non-inferiority margin was set at −10% The MITT population i

The non-inferiority margin was set at −10%. The MITT population included all subjects who received any amount of study drug according to their randomized

treatment group. The CE population included subjects in the MITT population who demonstrated sufficient FRAX597 adherence to the protocol. Baseline characteristics and demographics were comparable between the two study arms in each study. The majority of participants were Caucasian males with a median age of 48 years diagnosed with cellulitis, major abscesses and infected wounds/ulcers. Of the 76% of subjects with a pathogen isolated, S. aureus was the most common; the proportion with MRSA was 40% in the ceftaroline group and 34% in the vancomycin plus aztreonam group. Aztreonam or a saline placebo was discontinued

if a Gram-negative pathogen was not identified. A priori-defined integrated VEGFR inhibitor analysis of the primary endpoints demonstrated non-inferiority of ceftaroline in the MITT and CE populations (Table 3). In a planned secondary analysis of participants in the CE population with at least one pathogen isolated, clinical cure was achieved in 92.7% of the subjects in the ceftaroline treatment group compared with 94.4% receiving combination therapy (difference −1.7, 95% CI −4.9% to 1.6%) at TOC [47]. In bacteremic subjects, cure rates were 84.6% (22 of 26 subjects) in next the ceftaroline group compared to 100% (21 of 21 subjects) in the combination group (difference −15.4%, 95% CI −33.8% to 1.5%) [47]. In particular, cure rates among subjects with S. aureus bacteremia were lower in the ceftaroline group (88.9%), but not statistically different from the combination group (100%) with, notably, twice as many subjects having S. aureus bacteremia in the ceftaroline group than in the combination group (18 vs. 9, respectively). At late follow-up (21–35 days after completion of therapy), clinical

relapse rates were similar in the CE population: 1.1% and 0.9% in the ceftaroline and combination groups, respectively [47]. Post hoc analysis requested by the FDA to evaluate clinical response with cessation of lesion spread and apyrexia on day 3 of study therapy was conducted in a subgroup of 797 subjects and showed a weighted difference of 7.7% (95% CI 1.3–14.0%) in favor of ceftaroline [49]. Safety The safety profile of ceftaroline fosamil was evaluated in 1,740 participants and no unexpected safety concerns were identified [5, 48, 50, 51]. In the integrated FOCUS analysis, the most common adverse events occurring in greater than 2% of subjects receiving ceftaroline fosamil were diarrhea (4.2%), headache (3.4%), insomnia (3.1%) and phlebitis (2.8%) [50].

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